Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP) (AMYLYONCARP)

May 15, 2023 updated by: Centre Hospitalier Saint Joseph Saint Luc de Lyon
The purpose of this study is to evaluate the prevalence of amyloidosis in population of patient affected by suspect bilateral carpal tunnel with indication of surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69007
        • Recruiting
        • Centre Hospitalier Saint Joseph Saint Luc
        • Contact:
        • Principal Investigator:
          • Philippe SCHIELE, MD
        • Sub-Investigator:
          • Camille BARANI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • bilateral carpal tunnel with indication of surgery and judged suspect:
  • age of 50 years old and more
  • non-traumatic or undetermined neuropathic etiology or cardiac history (atrial arrhythmia or Heart Failure or cardiac stimulation) or family history of hereditary amyloidosis or monoclonal gammopathy

Exclusion Criteria:

  • patient with diagnosis of amyloidosis
  • traumatic bilateral carpal tunnel or linked to rheumatoid arthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of amyloid aggregate
Time Frame: During surgery
Research of amyloid aggregate in tenosynovial tissue
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Typing of amyloid aggregate
Time Frame: During surgery
Caracterization of amyloid aggregate in tenosynovial tissue
During surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Research of organ amyloidosis (context of standard care): exploratory
Time Frame: in the 3 months following surgery
Among positive patients, additional exams will be performed in the context of standard care in order to research for organ amyloidosis: blood sampling, EKG, echocardiography and other organ exams according to type of amyloidosis
in the 3 months following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Investigators

  • Principal Investigator: Philippe SCHIELE, MD, Centre Hospitalier Saint Joseph Saint Luc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2021

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMYLYONCARP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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